Study to Eliminate Hib Carriage in Rural Alaska Native Vi... | NCT00153556

Studies
Study to Eliminate Hib Carriage in Rural Alaska Native Villages

NCT00153556

Sponsor

Centers for Disease Control and Prevention

Status

Completed

Last Update Posted

Sep 12, 2005Estimated

Enrollment

3,200

Phase

Phase 4

Conditions

Haemophilus Influenzae Type B
Carrier State

Interventions

Hib conjugate vaccine (HbOC, Wyeth Vaccines)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Sep 2001

Primary Completion Date

Not provided

Completion Date

Nov 2003

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2005

Last Update Posted Date

Sep 12, 2005Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Centers for Disease Control and PreventionFED

Collaborators

Name	Class
CDC-Arctic Investigations Program	UNKNOWN
Alaska Native Tribal Health Consortium	OTHER
Yukon Kuskokwim Health Corporation	OTHER
Alaska State Public Health Laboratories

Description Module

Brief Summary

Hib disease rates in rural Alaska before introduction of HIb conjugate vaccine were among the highest in the world. Since vaccine introduction, rates have fallen by 90% but the disease has not been eliminated. This study is designed to test one possible means of eliminating Hib carriage and thus to eliminate person to person transmission and invasive disease.

The objective of this study is to evaluate the effectiveness of community-wide use of Hib conjugate vaccine for eliminating oropharyngeal Hib carriage in rural Alaska villages.

Secondary objectives include:

Determine risk factors for Hib OP carriage including demographic characteristics, and immunologic characteristics (antibody level and function). This will be accomplished through a case-control study described below.
Measure antibody response to Hib conjugate vaccine among adults who have not previously received Hib vaccine. This will be accomplished through a cohort study of participating adults in the vaccine intervention communities.

Detailed Description

This was a pilot intervention to assess the feasibility of using Hib conjugate vaccine to eliminate Hib carriage in rural Alaska villages, with three villages to serve as a comparison group. WE performed community-wide surveys of Hib carriage by recruiting volunteers for throat cultures to establish a baseline rate of Hib carriage for each community. Then Hib carriers were offered chemoprophylaxis to clear Hib from their throats. In the vaccine intervention communities, a single dose of Hib conjugate vaccine was offered to persons of all ages. This was followed by a second community-wide Hib carriage survey after one year to assess the effectiveness of the intervention.

Conditions Module

Conditions

Haemophilus Influenzae Type B
Carrier State

Keywords

Haemophilus influenza type B
Carrier state
Bacterial Vaccines
Anti-PRP antibody
Antibody avidity
Serum bacteriocidal antibody
American Indians/Alaska Natives
Case control study
Adult vaccines

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3,200

Name	Type	Description	Arm Group Labels	Other Names
Hib conjugate vaccine (HbOC, Wyeth Vaccines)	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in community-wide oropharyngeal Hib colonization one year after administration of a single dose of Hib vaccine to all willing community members in 3 villages vs. change in HIb colonization in 3 village where Hib vaccine was used routinely

Secondary Outcomes

Measure	Description	Time Frame
- Safety of HIb vaccine given to adults
- Anti-PRP antibody/ avidity/ serum bacteriocidal activity among adult vaccine recipients, Hib colonized persons and age-matched controls

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All village residents are eligible for Hib colonization survey
All residents of selected villages eligible for vaccine study except as noted below.

Exclusion Criteria:

For receipt of vaccine:
history of allergic reaction to Hib vaccine or components
Age < 24 months and not due for Hib vaccine according to childhood immunization schedule
Age > 24 months and have received HIb vaccine within past year
Pregnant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas W Hennessy, MD,MPH	Centers for Disease Control and Prevention-Arctic Investigations Program	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CDC Arctic Investigations Program		Anchorage	Alaska	99508	United States

Condition Browse Module

MeSH Terms

ID	Term
D006192	Haemophilus Infections

Ancestor Terms

ID	Term
D016871	Pasteurellaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

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